WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

Atrial Fibrillation Clinical Trial

Official title:

WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173534
• Other study ID #: WATCH-TAVR
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: December 6, 2022

Study information

• Verified date: May 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR).

Description:

WATCH-TAVR is a prospective, multicenter, randomized controlled trial. Only centers with approval for commercial WATCHMAN implantation will be included in this trial. Subjects will be enrolled at up to 32 centers in the United States. There will be up to 350 subjects enrolled, with 175 patients randomized to TAVR + medical therapy and 175 patients randomized to simultaneous TAVR+WATCHMAN to accumulate the necessary 191 primary events. Enrollment is expected to occur over the course of 18 months. Patients will be followed for a total of 2 years. Patients with non-valvular AF undergoing standard of care commercial TAVR will be enrolled in the trial.

For patients who receive the WATCHMAN device, plan of care will follow WATCHMAN labeling.Patients randomized to receive the WATCHMAN device will receive anticoagulation with warfarin and aspirin for 6 weeks after the procedure. After 6 weeks, the plan of care will follow WATCHMAN labeling. Patients randomized to the TAVR + medical therapy arm will be treated in accordance with standard of care with either warfarin, other anticoagulant/antiplatelet therapy, or no anticoagulation at the discretion of the treating physician. All patients will continue to receive routine post-TAVR follow-up and care.Patients will be monitored for primary and secondary endpoints as outlined. Baseline information and laboratory data will be collected as described in the protocol.

At trial conclusion, total number of subjects enrolled was 349. There were 172 subjects enrolled in the TAVR + Medical Therapy arm and 177 subjects enrolled in the TAVR + WATCHMAN arm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women = 18 years of age.

2. The patient meets criteria for and is scheduled to undergo TAVR procedure

3. The patient has documented paroxysmal, persistent, or permanent atrial fibrillation.

4. The patient meets the WATCHMAN labeling guidelines and is eligible to undergo the WATCHMAN implantation procedure.

5. The patient is eligible for short term warfarin therapy.

6. The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial.

7. The patient is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:

1. The patient had a stroke or TIA within the last 6 months prior to enrollment.

2. Contraindication for short term anticoagulation.

3 .Moderate or severe Mitral Stenosis with mean gradient across Mitral Valve >10 mm Hg or Mitral Valve Area < 1.2cm2.

4. The patient has symptomatic carotid disease (i.e.,carotid stenosis = 50% associated with ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months).

5. Prior occlusion of LAA.

6. The patient has an implanted mechanical mitral valve.

7. The patient requires long-term warfarin therapy due to:

1. Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months

2. The patient is in a hypercoaguable state; exclude the patient if per medical record documentation, the patient meets any of the following criteria:

• Thrombosis occurring = 40 years of age

• Idiopathic or recurrent VTE (venous thrombo-embolism)

• Thrombosis at an unusual site (cerebral veins, hepatic veins, renal veins, IVC, mesenteric veins)

• Family history of VTE or of inherited prothrombotic disorder, recurrence/extension of thrombosis while adequately anticoagulated.

8. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable).

9. The patient is pregnant or pregnancy is planned during the course of the investigation if patient is of child bearing potential.

10. Any clinically significant medical condition or presence of any laboratory abnormality prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study or not meeting procedure guidelines for TAVR or WATCHMAN.

11. The patient has a life expectancy of less than two years.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Atrial Fibrillation

Intervention

Device:
• WATCHMAN
WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.
• TAVR
Transcatheter Aortic Valve Replacement

Locations

Country	Name	City	State
United States	Austin Heart	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University at Buffalo	Buffalo	New York
United States	Sutter Health/Palo Alto Medical Foundation	Burlingame	California
United States	The Cleveland Clinic	Cleveland	Ohio
United States	OhioHealth Research Institute	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Parkview Research Center	Fort Wayne	Indiana
United States	St. Vincent Heart Center	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Baptist Health Jacksonville	Jacksonville	Florida
United States	UCHealth Medical Center of the Rockies	Loveland	Colorado
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Columbia University Medical Center	New York	New York
United States	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
United States	CHI Health Research Center	Omaha	Nebraska
United States	Banner University Medical Center	Phoenix	Arizona
United States	Heart Hospital Baylor Plano	Plano	Texas
United States	Medstar Washington University	Saint Louis	Missouri
United States	Northside Hospital	Saint Petersburg	Florida
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Prairie Cardiovascular Consultants	Springfield	Illinois
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	Aspirus Research Institute	Wausau	Wisconsin
United States	Lexington Cardiology	West Columbia	South Carolina
United States	Pinnacle Health	Wormleysburg	Pennsylvania
United States	WellSpan York Hospital	York	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
samir kapadia	Boston Scientific Corporation, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular Mortality	Cardiovascular related mortality through 2 year	Through 2 year post-randomization
Other	Thrombus or Embolism	Incidence of arterial or venous embolism	Through 2 year post-randomization
Other	Re-hospitalization	Incidence of re-hospitalizations related to the WATCHMAN procedure or WATCHMAN device	Through 2 year post-randomization
Other	Quality of Life Score: KCCQ-12	Change from baseline in quality of life (QoL) as measured using the KCCQ-12 score. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated tool used to assess heart failure and how it affects the participant's life. Four domain scores and one summary score are generated from the KCCQ-12: Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score and a Summary Score. Scale ranges for each question 1 to 6 (Extremely limited 1, Quite a bit limited 2, Moderately limited 3, Slightly limited 4, Not at all limited 5, Limited for other reasons or did not do the activity 6. The Summary score represents an integration of the patient's physical limitation, symptom frequency, quality of life and social limitation. The total score is calculated as the average of the above scale descriptions. Scores are scaled 0-100, where 0 denotes the lowest reportable health status. Scores of 100 indicate the highest reportable health better outcome status.	Through 2 year post-randomization
Other	Procedural Costs	Procedural costs related to the initial TAVR and WATCHMAN procedures	Mean cost during hospitalization up to 40 days.
Primary	Composite of All-cause Mortality, Stroke and Bleeding	First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 2 years post-randomization.	Through 2 year post-randomization
Secondary	All-cause Mortality	All deaths through 2 year	Through 2 year post-randomization
Secondary	Stroke	First occurrence of any ischemic or hemorrhagic stroke through 2 year	Through 2 year post-randomization
Secondary	Bleeding	First occurrence of any life-threatening or major bleeding through 2 year	Through 2 year post-randomization